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A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443324
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : August 18, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Adenocarcinoma of the Gastroesophageal Junction Non-small Cell Lung Cancer Carcinoma, Transitional Cell Biliary Tract Cancer Drug: Ramucirumab Drug: Pembrolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus Pembrolizumab in Patients With Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
Actual Study Start Date : July 29, 2015
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : April 12, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ramucirumab + Pembrolizumab (Phase 1a Schedule 1)
Gastric-GEJ, BTC: Ramucirumab given intravenously (IV) on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Ramucirumab + Pembrolizumab (Phase 1a Schedule 2)
Gastric, NSCLC, Urothelial: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort A)
Gastric-GEJ: Ramucirumab given IV on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort A1)
BTC: Ramucirumab given IV on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort A2)
Gastric-GEJ (first line only): Ramucirumab given IV on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort B)
Gastric-GEJ: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort C)
NSCLC: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort D)
Urothelial: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475
Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort E)
NSCLC: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
 Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

Drug: Pembrolizumab
Administered IV
Other Name: MK3475


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: Baseline to Measured Progressive Disease (Estimated up to 24 Months) ]

Secondary Outcome Measures :
  1. Proportion of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] [ Time Frame: Baseline to Measured Progressive Disease (Estimated up 24 Months) ]
  2. Proportion of Participants who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] [ Time Frame: Baseline to Measured Progressive Disease (Estimated up 24 Months) ]
  3. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up 24 Months) ]
  4. Time to First Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up 24 Months) ]
  5. Progression Free Survival (PFS) [ Time Frame: Baseline to Progressive Disease or Death of Any Cause (Estimated up 24 Months) ]
  6. Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Estimated up 24 Months) ]
  7. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Day 1 Cycle 1 through Cycle 9 Day 1 (21 Day Cycles) ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic disease or locally advanced, unresectable disease.

    • Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 0-2 prior lines of systemic therapy
    • Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 0-3 prior lines of systemic therapy
    • Has histopathologically confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
    • Has histologically confirmed biliary tract adenocarcinoma with documented progression after 1-2 prior lines of systemic therapy
  • Availability of tumor tissue for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy. For first line NSCLC participants only, PD-L1 expression should be 1% or higher.
  • Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Has adequate organ function.
  • Have an anticipated life expectancy of ≥3 months.

Exclusion Criteria:

  • Have known brain metastases.
  • Has received ≥3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ≥4 lines for NSCLC or urothelial cancer.
  • Has active autoimmune disease.
  • Known human immunodeficiency virus (HIV) infection.
  • Known active hepatitis B or hepatitis C infection.
  • Has received any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or VEGF receptor, or programmed death (PD) 1 or PD-ligand 1/2 signaling pathways.
  • Have received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
  • Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
  • Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443324


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8020
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists and Research Institute
Saint Petersburg, Florida, United States, 33705
United States, Tennessee
Tennessee Oncology PLLC
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dijon Cedex, France, 21034
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lille Cedex, France, 59020
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lyon Cedex 08, France, 69373
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris CEDEX 05, France, 75248
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dresden, Germany, 01307
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Heidelberg, Germany, 69126
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tübingen, Germany, 72076
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kochi-Shi, Japan, 780-0051
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yamanashi, Japan, 400-0124
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, Spain, 08035
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, Spain, 28050
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pamplona, Spain, 31008
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, United Kingdom, W1G 6AD
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Manchester, United Kingdom, M20 4BX
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Eli Lilly and Company
Merck Sharp & Dohme LLC
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02443324    
Other Study ID Numbers: 15787
I4T-MC-JVDF ( Other Identifier: Eli Lilly and Company )
2015-001473-40 ( EudraCT Number )
KEYNOTE -098 ( Other Identifier: Merck )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Keywords provided by Eli Lilly and Company:
immuno-oncology
Vascular Endothelial Growth Factor (VEGF)
angiogenesis
PD-1
carcinoma of the bladder
 carcinoma of the urethra
carcinoma of the ureter
carcinoma of the renal pelvis
carcinoma of the biliary tract
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Biliary Tract Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Digestive System Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Pembrolizumab
Ramucirumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors